Answers to Frequently Asked Questions about ESI MIRA PAR-20-117

Answers to Questions Cover the Following Topics:

  1. ESI MIRA Program Description
  2. Eligibility Information
  3. Application and Submission Information
  4. Budget Information
  5. Review Information
  6. Post Review Issues
  7. Award Process Information
  8. Post Award Concerns
  9. Prior Approval Issues

I. ESI MIRA Program Description

What is the NIGMS ESI MIRA program and what is its purpose?

The NIGMS ESI MIRA is a grant to provide support for a program of research in an early stage investigator's (ESI) laboratory that falls within the mission of NIGMS. For the purposes of MIRA FOAs, a research program is defined as a collection of scientific projects in an investigator’s lab that are related to the mission of NIGMS. The purpose is to increase funding stability while offering investigators the flexibility to follow important new research directions as opportunities arise; to more widely distribute funding among NIGMS investigators and increase the efficiency and efficacy of NIGMS funding; to reduce time spent writing, reviewing and managing multiple research grants and thus provide more time for research and mentoring junior scientists. The ESI-MIRA program does not require preliminary data, which should enable investigators to apply earlier in their independent careers and move into research areas that are distinct from those of prior mentors.

What scientific areas of research fall within the NIGMS mission and are appropriate for support through MIRA?

Any research area within the mission of NIGMS is eligible for support on a MIRA. Research areas supported by NIGMS are outlined on the NIGMS website. However, some types of research (e.g., clinical studies, technology development, or team science) might be better suited for more traditional grant mechanisms. We strongly encourage applicants to discuss their planned proposal with NIGMS program staff well in advance of submission, since applications outside of the NIGMS mission will be returned to the applicant without review.

How can I find out if my research is related to the mission of NIGMS?

NIGMS supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. The specific areas of research that fall into this general mission can be found at the NIGMS overview page and on the web pages of the NIGMS scientific divisions. In particular, note that NIGMS-supported research may utilize specific cells or organ systems if they serve as models for understanding general principles. Research whose overall goal is to gain knowledge about a specific organ or organ system, or the pathophysiology, treatment, or cure of a specific disease or condition will, in most cases, be more appropriate for another NIH Institute or Center and thus will not be suitable for this Funding Opportunity Announcement.

Can a MIRA support clinical/translational research?

Yes. Clinical and translational research within the NIGMS mission may be supported through a MIRA. NIGMS supports research in specific areas that affect multiple organ systems; anesthesiology and peri-operative pain; sepsis; clinical pharmacology that is common to multiple drugs and treatments; trauma, burn injury, and wound healing (Division of Pharmacology, Physiology, and Biological Chemistry).

Pre-application discussion of clinical/translational research projects with an NIGMS program director managing the qualifying award is strongly encouraged. Such research can also be added after award of the MIRA, as a change in scope, provided NIH approval is obtained prior to initiating the studies.

Can the topic of a MIRA be multiple distinct research directions?

MIRA is intended to enable consolidation of NIGMS support for multiple projects that may be disparate, so there is no obligation to develop a single unifying theme. Applicants should directly address the rationale underlying the balance of effort and the resources dedicated to each activity, and how the activities are distinct or complementary.

What about research focused primarily on HIV/AIDS?

The HIV/AIDS structural biology program that used to be managed by NIGMS has transitioned to NIAID, so it cannot be part of an NIGMS-funded MIRA.

Can technology development be included or is the award only for hypothesis-driven research?

Yes. Technology development can be an essential part of any research program and hypothesis-driven science is only one way of approaching a research problem. However, a program aimed almost exclusively at technology development may be more appropriately supported by other mechanisms.

Who makes the final decision about whether a MIRA application is responsive and within the NIGMS mission, and when?

This decision is made by NIGMS program officials, division directors and NIGMS leadership. A preliminary determination may be made by contacting NIGMS staff. However, a final decision will only be made based on the submitted application itself.

When will I know whether my application was accepted or rejected based on responsiveness to the NIGMS mission and how will that decision be made?

This process should be completed within a few weeks after the receipt date. Investigators whose applications are returned without review will be notified ASAP.

How much time/effort must recipients devote to MIRA? How many calendar months?

A MIRA PI must devote at least 51 percent of his or her total research effort to the MIRA. Research effort is calculated differently than professional effort in that research effort does not include effort expended toward teaching, administration and/or clinical duties. It should be reported as calendar months.

For example, if an investigator has two grants (including the MIRA) with 50 percent total effort between them, he or she must devote a minimum of 25.5 percent effort to the MIRA (50 percent total research effort x 51 percent MIRA effort requirement = 25.5 percent must be devoted to the MIRA), regardless of the amount of salary support requested. This would be equal to 3.06 calendar months of effort (25.5 percent x 12 calendar months = 3.06 months).

PIs must devote at least 51 percent of their total research effort, but a higher level of PI research effort is permitted. The total research effort should be calculated based on an investigator’s expected level of research effort should the MIRA application be funded.

Investigators cannot simultaneously hold another award that requires 50 percent or more research effort. NIGMS will not make a MIRA while such awards are active or pending. The pending applications must be withdrawn before the MIRA will be issued.

How much salary support can be requested?

Salary may be requested based on the institutional base salary level for up to an amount commensurate with the number of calendar months of effort committed to the MIRA. A lower level of salary support may be requested; NIGMS does not consider there to be an obligatory relationship between percent of annual effort and percent of annual salary recovered from the grant as long as the salary requested is not in excess of the effort committed to the grant.

Can I continue to work with my current collaborators?

Yes. NIGMS strongly endorses collaborative research. However, the MIRA concept is based on the idea that NIGMS will provide support to individual investigators’ research programs. Collaborators will work together because of their mutual interest in a problem, not through a subcontract. In cases where a collaborator’s efforts are well-justified, essential to the research program of the MIRA and cannot be supported by the collaborator, a consortium agreement may be included. Please note, however, that as stated in the PAR, applications involving a consortium/contractual arrangement are expected to be rare. If a consortium/contractual arrangement must be included, the application must also include a letter from the collaborating PD/PI indicating why they cannot participate in collaborative research with the PD/PI without support from the MIRA.

Can I work with foreign collaborators?

Yes. NIGMS supports international collaborative research efforts, and investigators are encouraged to pursue scientifically productive collaborations. In cases where a foreign collaborator’s efforts are well-justified, represent a unique scientific opportunity, are essential to the research program of the MIRA and cannot be supported by the foreign collaborator, a consortium agreement with a foreign institution can be included. Please note, however, that as stated in the PAR, applications involving a consortium/contractual arrangement are expected to be rare. If a consortium/contractual arrangement must be included, the application must also include a letter from the subcontract PD/PI indicating why they cannot participate in collaborative research with the PD/PI without support from the MIRA. Please also note that foreign collaborations added after review require written approval by NIGMS staff.

Can I name a Co-Investigator in my application?

As indicated in the NIH glossary, Co-Investigators are defined as collaborators and are considered equivalent to senior/key personnel. The Co-Investigator designation does not affect the PI's roles and responsibilities as specified in the NIH Grants Policy Statement, does not imply that there are multiple PIs, and does not confer any advantages or responsibilities on the individual in question beyond those of a collaborator or senior key person. Applicants should therefore consider whether designation as a collaborator might be sufficient. Applicants should also keep in mind that the MIRA concept is based on the idea that NIGMS will provide support to individual investigators’ research programs and that funding for collaborators of any kind is expected to be rare. Collaborators will work together because of their mutual interest in a problem. In rare cases where a collaborator’s efforts are well-justified, essential to the research program of the MIRA and cannot be supported by the collaborator, a consortium agreement or request for salary support can be included. If a consortium/contractual arrangement or salary for a collaborator must be included, the application must also include a letter from the collaborator indicating why they cannot participate in collaborative research with the PD/PI without support from the MIRA. If the justification provided is deemed insufficient by review or by NIGMS leadership, the requested funds may be removed prior to award.

Can I collaborate with an NIH intramural scientist?

Yes, a MIRA investigator can collaborate with an intramural scientist, but no funds can be provided to the intramural laboratory from the MIRA. If involvement with an intramural lab is a substantial part of the investigator's research program, a MIRA may not be a suitable means of support.

Can you clarify how much flexibility is meant by "flexibility to pursue new research directions"?

This must be considered on a case-by-case basis and requires the application of reasonable judgment by both the investigator and NIGMS staff. The extension of studies on a problem from one organism to another would be reasonable. Insights gained from studying one biological problem that extend the project into another within the mission of NIGMS would also be reasonable. When in doubt, you should discuss changes with the NIGMS program director.

What would be considered within or outside the scope of a MIRA?

Any research in the PI’s lab that falls within the NIGMS mission and does not introduce changes related to substantive grants policy issues would be considered within scope. Changing research direction within scope, i.e., within the NIGMS mission, does not require prior approval by NIGMS.

A MIRA may change in scope for reasons related to grants policy or for scientific reasons. Policy-related changes in scope would include the addition, or a change in the approved use, of human subjects, vertebrate animals, select agents or human embryonic stem cells. These changes require prior approval by NIGMS before the work is initiated. However, such changes in scope can be approved with appropriate documentation. On the other hand, work that migrates away from the NIGMS mission and into the mission of another NIH institute or center would be considered scientifically out of scope. The budget of MIRA grants that are determined to be out of scope scientifically may be reduced in non-competing years, or the award may be terminated. If you are unsure whether or not your new research direction is within the NIGMS mission, contact your NIGMS program director.

Why does NIGMS think that this initiative will enhance the quality of science generated by its community of grantees?

MIRA-supported investigators will have the flexibility to pursue the science they want to do as it evolves, rather than being held to specific aims that they proposed before they received a grant. In this way, they will have greater flexibility to try ideas that might be considered high-risk. MIRA is expected to result in more stable funding of investigators, better continuity of effort and better ability to keep well-trained personnel in the laboratory. MIRA is also expected to broaden the distribution of funding among laboratories, enabling more of the nation's highly talented and promising investigators to participate.

II. Eligibility Information

Who is eligible to apply for the ESI MIRA?

Principal investigators who meet the following requirements are eligible to apply for PAR- 20-117:

  • proposes research in an area within the NIGMS mission
  • has an ESI status = ‘Yes’ in eRA Commons
  • has an independent research appointment at an eligible organization

Research Area:Research areas supported by NIGMS are outlined on the NIGMS website. However, some types of research (e.g., clinical studies, technology development, or team science) might be better suited for more traditional grant mechanisms (e.g., R01, R21). Applicants are strongly encouraged to discuss their planned proposal with NIGMS program staff well in advance of submission, since applications outside of the NIGMS mission will be returned to the applicant without review.

ESI: NIH defines early stage investigators (ESIs) as new PIs who are within 10 years of having received their Ph.D. degree or completing medical residency (or the equivalent), and have not yet received R01-equivalent grant support (i.e., R01, R35, R37, DP1, DP2, U01 or SC1 grant awards). Your eRA Commons account indicates your ESI status and provides links to request extensions to your ESI status (found in the Education section of the PI’s Personal Profile in eRA Commons), which are granted for a limited number of reasons – refer to NOT-OD-09-034 and NOT-OD-19-125 for more information.

Independent Research Appointment: If your institution defines your position as one that permits you to submit an NIH grant application as an independent principal investigator of a research project grant, then you may apply. If you are not in an independent position, as is true for most postdoctoral fellows and many NIH Career Development “K” Awardees, then you may not apply. Eligibility is not related to academic rank (Assistant vs. Associate Professor) or to having a tenure-track position. Women and members of underrepresented groups who meet the other eligibility requirements are strongly encouraged to apply.

Eligible organization: Refer to the Section III. Eligibility Information of FOA PAR-20-117.

Is there any additional guidance regarding the eligibility of K awardees?

K99 awardees who have not yet transitioned to an independent position may not apply. R00 awardees who have transitioned to an independent position may apply. If your K award is from another NIH institute (e.g., NHBLI, NINDS, NIDDK, NICHD), then there is a good chance that your area of interest is most closely aligned with the mission of that institute, rather than NIGMS.

What if I currently hold a SCORE award?

If you currently hold a SCORE SC1 award (not applicable to SC2, SC3), then you are NOT eligible. NIGMS considers the SC1 to be a substantial form of support equivalent to an R01, so that you are no longer considered a new PI. See the SCORE Answers to Frequently Asked Questions.

If you currently hold an SC2 or SC3 award and are otherwise eligible, you may apply. If you are successful in receiving a MIRA, the SCORE award would be terminated or phased out.

What if I currently have support from an IDeA COBRE award?

If you are an IDeA junior investigator and are otherwise eligible, you may apply. The PI of an NIGMS IDeA grant is expected to be an established scientist and would not be eligible. If the junior investigator’s support on the IDeA includes NIGMS-relevant specific aims, the NIGMS-related support will be terminated prior to the start of the MIRA. The award level of the IDeA grant is not reduced. However, the IDeA PI is informed what portion of the funds (all or partial) can no longer be made available to the junior investigator who will receive the MIRA.

What if I currently hold an AREA R15 grant?

You are eligible to apply if you have ESI status. If you receive a MIRA, the award may be adjusted to account for funds that you have already received for the AREA grant. This adjustment will apply to AREA grants that were awarded by NIGMS. However, if the PI has previously been supported by another institute of the NIH, the PI should be sure to check with an NIGMS program director to be sure the proposed work falls within the mission of NIGMS.

Are scientists in the NIH intramural research program eligible to apply?

No, NIH intramural research scientists are not eligible to apply. A MIRA application can include a collaboration with an intramural scientist, but no MIRA funds can be provided to the intramural laboratory. A MIRA will not be converted to a cooperative agreement. Therefore, if involvement with an intramural lab is a substantial part of the investigator's research program, a MIRA may not be a suitable means of support.

Can a MIRA PI apply for other NIGMS R01, R15 or R21 grants?

NIGMS will not fund an application for a research award where the MIRA PI is the PI or a multi-PI. The MIRA PI can participate in other NIGMS research applications as a collaborator (Other Significant Contributor) but cannot receive any funds from the grant.

Can a MIRA PI be a PI or a project lead on a RM1 or other multiple component project?

Yes, a MIRA PD/PI may participate in a RM1 project as part of the PD’s/PI’s 51% total research effort. The MIRA PD/PI will not request or receive research funds from the RM1 while the PD’s/PI’s research program is supported by MIRA.

Can a MIRA PI apply for NIGMS Center grants?

The MIRA PI can participate in other NIGMS large-scale research grants as a Core Leader if the purpose of the Core is solely to provide a service. The MIRA PI can participate in Center and other large scale research applications as an Other Significant Contributor (i.e., collaborator), but cannot receive any funds from the grant.

What other NIGMS funding opportunities can a MIRA PI apply for?

These applications are explicitly allowed:

  • Grants supporting resources for the research community (e.g., P30, R24);
  • Biomedical Technology Development and Dissemination program RM1 grants;
  • Contracts;
  • Grants supporting training, workforce development, or diversity building;
  • Funding for clinical trials;
  • INBRE (P20), COBRE (P20/P30), or IDeA-CTRs (U54);
  • SBIR/STTR grants;
  • Conference grants;
  • Research Supplements to Promote Diversity in Health-Related Research, and certain types of administrative supplements, including equipment supplements that may be offered by NIGMS through FOAs in the NIH Guide.
  • MIRA PIs are not prevented from submitting applications to other NIH Institutes.

If I have an appointment at more than one institution, can I apply for a separate MIRA through each institution?

No. An investigator can only have one MIRA, which should be submitted by the institution where he or she primarily conducts his or her research program. Under rare circumstances, a subcontract might be permitted to support a part of the research program that is based at a different institution.

Can I obtain a second appointment at another domestic or foreign institution after I receive a MIRA?

A PD/PI is expected to commit at least 51% of his/her total research effort to MIRA as originally reviewed and approved. Significant change of research environment will be evaluated by NIGMS staff on a case-by-case basis, and may lead to a reduction of budget level, reduction in duration of support, or termination of the MIRA award.

How can I find out if my research is related to the mission of NIGMS?

NIGMS supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. The specific areas of research that fall into this general mission can be found at the NIGMS overview page and on the web pages of the NIGMS scientific Divisions. In particular, note that NIGMS-supported research may utilize specific cells or organ systems if they serve as models for understanding general principles. Research whose overall goal is to gain knowledge about a specific organ or organ system, or the pathophysiology, treatment, or cure of a specific disease or condition will, in most cases, be more appropriate for another NIH Institute or Center and thus will not be suitable for this Funding Opportunity Announcement.

Use the NIH RePORTER. You can search using keywords, or find similar applications funded by NIH and note the funding institute. The Matchmaker tab is particularly useful. You can enter your abstract and look for scientific matches. Finally, if you have submitted your proposed studies in an application to NIH before, and it was assigned any other institute, this decreases the likelihood that the research falls within the scientific mission of NIGMS.

What happens if I submit a MIRA application that NIGMS finds does not fall within its mission?

The application will be returned without review.

Can I apply for extension of my ESI status?

Yes. Extensions of ESI status are granted for a number of reasons, including family care responsibilities, extended periods of clinical training, extended periods of additional (non-degree) research training, disability or illness, active duty military service, federal loan clinical service requirements, and natural or other disasters. See New and Early Stage Investigator Policies.

Do I need to have prior NIGMS support?

No, you do not. You may have received support from other institutes previously (e.g., through R03 or R21 awards), but if you are otherwise eligible and the proposed work is within the mission of the NIGMS, you may apply. However, the fact that your previous work was supported by another part of NIH may be an indication that the work really is of interest to one of the other institutes.

May two or more ESI scientists apply as a team for an NIGMS MIRA?

No. This FOA is intended to provide support for the NIGMS mission-related research program of a single independent investigator and multiple-PI applications are not allowed. While team science is an important component of the biomedical landscape, this MIRA PAR is focused on supporting the individual laboratories of newly independent investigators.

Will revised MIRA grant applications be accepted?

Revised applications may not be submitted in response to PAR-20-117. You may submit a NEW application on the same general topic as the one you submitted previously if you are still considered an ESI. The new application should make no reference to the previous application or its review. However, you may wish to change the application to address concerns raised during the previous review.

Can I submit a MIRA and an R01 application at the same time?

Yes. PAR-20-117 specifically states: “It is anticipated that the MIRA review will be highly competitive; therefore, a PD/PI may submit an R01 application and a MIRA application in parallel. Should both applications be selected for funding, the PD/PI will be required to relinquish one of the awards.” This means that ESI PIs may submit an R01 to the June 5, October 5, or February 5 deadlines in addition to submitting a MIRA in October.

Can I submit an overlapping ESI MIRA application and a DP2 New Innovator Award application at the same time?

No. The NIH Common Fund DP2 Funding Opportunity Announcement states: "The NIH will not accept duplicate or highly overlapping applications under review at the same time.

III. Application and Submission Information

Is there a limit on the number of applications that can be submitted by a PI? By an institution?

An investigator may be the PI on only one application for a MIRA in any one year. There is no limit on the number of applications that can be submitted by an institution, provided they are for support of the research programs of different independent eligible investigators.

Can I get advice on my ideas for submission of a MIRA application?

You may discuss your ideas with the program contacts named in PAR-20-117 or with the program officer who manages the portfolio of NIGMS applications and awards closest to your research. Portfolio descriptions can be found on the NIGMS website: Contacts by Research Area.

What became of the specific aims section of the grant application?

Specific aims are not allowed because a goal of MIRA is to move the scientific enterprise away from a focus on narrowly defined research projects with detailed specific aims and to refocus attention on the larger picture and potential overall impact of the research. If your institution’s system for submitting a grant application gives you a warning and will not allow you to skip the specific aims page, enter the following text in the appropriate place: “Per the FOA instructions, no specific aims are to be submitted.”

What format should the application follow?

Follow the instructions in the SF424 R&R application guide [PDF] as modified by the instructions in the FOA. In brief, this means that the scientific content of the application will rely mainly on the abstract, public health relevance statement, facilities and other resources page, biosketch and the six-page research strategy, plus details on the involvement of human subjects and vertebrate animals as necessary. Applications must also provide data/resource sharing and key resource authentication plans. Avoid duplicating material covered in other sections. Do not include lists of publications, except as part of the biosketch, or references except as necessary in the Bibliography & References Cited section of the Other Project Information Form.

Why is the research strategy section only six pages?

Because the goal of MIRA is to focus the investigator’s and reviewers’ attention on higher level questions about significance and impact of the research program, details in the research plan can be reduced. Furthermore, changes in the biographical sketch mean that much of the needed information about the recent past research contributions of the investigator can be presented there, rather than in the research plan.

Do I need to submit a plan for the authentication of key resources?

Yes. All MIRA applications must include a plan describing how key biological and/or chemical resources will be authenticated.

How do I handle the Vertebrate Animals Section? Do I need to address sex as a biological variable?

There is no change in the format/requirements for the Vertebrate Animals Section (VAS) of the MIRA application. MIRA applicants should follow current instructions on preparing the Vertebrate Animals section of the research plan [PDF, 6MB]. If you plan to use live vertebrate animals (including production of custom antibodies and animals obtained for their tissues), but do not yet have detailed plans, you must still include a Vertebrate Animals Section. You will need to answer "yes" to the question "Vertebrate animals, yes or no" in Item 2 of the Other Project Information component in your grant application package. Your application also covers all performance sites, including sub-award partners, collaborators, contractors and others involved in animal research. Even if the only animal work that will be done from your R35 application will be performed somewhere other than your institution (e.g., you plan to have an antibody made by an outside contractor) you must mark "yes" and follow the instructions for Vertebrate Animals in the SF424 Form Instructions and include a Vertebrate Animal Section (VAS, see Vertebrate Animal Worksheet).

NIH expects that sex as a biological variable will be factored into research designs, analyses and reporting in vertebrate animal and human studies. Strong justification from the scientific literature, preliminary data or other relevant considerations must be provided in the Research Strategy for applications proposing to study only one sex. If you have designed your studies and they will be discussed in your R35 application, you should provide this information in your VAS for points 1 to 3 (Description of Procedures, Justifications, and Minimization of Pain and Distress) so the study section can rate your VAS as acceptable or unacceptable.

If you plan to use animal studies in your MIRA application but have not defined your plans about the species, sex, protocols and procedures to minimize pain and distress, or other information required for submission for your institutional animal care and use committee (IACUC) approval and a completed VAS in your application, please indicate that animals will be used in your application on the appropriate pages of your application and include a VAS in your application with as much of the information that you can provide. But for those topics that you do not have definite information, indicate that animal studies will have a delayed onset.

At the appropriate time after review, you will be asked for your IACUC approval of your research protocols. If your plans remain uncertain, a restricted notice of grant award will be issued that bars the use of funds for vertebrate animal research until prior NIH approval is obtained.

Can a MIRA support human subjects and clinical/translational research?

Yes. Clinical and translational research within the NIGMS mission may be supported through a MIRA. Clinical research must be completely within the context of the NIGMS clinical areas (anesthesiology, clinical pharmacology, sepsis, injury and critical illness). Mechanistic clinical trials are permitted in MIRA when the mechanistic study is an essential part of the research program. Clinical research that involves recruitment of human subjects at more than one site or the substantial financial support of multiple collaborators and subcontractors is not allowed, because these fixed commitments are not consistent with the highly flexible nature of the MIRA program. Clinical trials that are designed to test safety and efficacy of interventions (Phase I, Phase II, Phase III) for the purpose of future clinical treatment and/or regulatory approval are not permitted in MIRA. Pre-application discussion of clinical/translational research projects with an NIGMS program director is encouraged.

How do I prepare the Protection of Human Subjects section?

There is no change in the format/requirements for the Protection of Human Subjects section in the MIRA application. MIRA applicants should use the PHS Human Subjects and Clinical Trials Information form. Please note that study records should be entered for delayed start human subjects studies, i.e. a study that can be described at the time of application but will not begin at the time of award. The delayed onset human subjects study section only applies to studies for which definite plans for human subjects involvement cannot be described at the time of application.

Is delayed-onset human subjects research permitted in a MIRA?

Yes, both delayed start and delayed-onset human subjects research are permitted in MIRA awards. MIRA awardees should submit a prior approval request to their program director to add human subjects research to their MIRA. Prior approval requests should contain IRB approval of the human subjects study as well as a complete PHS Human Subjects and Clinical Trials Information form.

What approvals are required to add human subject studies to my MIRA project or to initiate "delayed onset" human subject studies?

MIRA awardees can submit a prior approval request to their program director to add human subjects research to their MIRA or to initiate "delayed onset" studies. Prior approval requests should contain IRB approval of the human subjects study as well as a complete PHS Human Subjects and Clinical Trials Information form.

Do I need to include a resource sharing plan?

All applications, regardless of the amount of direct costs requested for any one year, should address a Resource Sharing Plan that describes plans to share and store data and other resources, including model organisms and genomic data.

What may I include in the appendix?

Only the items listed in NOT-OD-17-098, plus any additional items if specifically listed in the individual funding opportunity announcement as required or optional.

Should I submit letters of support?

Yes. A letter of support should be included from the department chair, dean, or other academic unit leader that describes institutional commitment to the development of the investigator and any other pertinent information. This information could include start-up packages and other institutional research support, space available to the PD/PI, salary support commitment for the PD/PI, skills and career development opportunities for the PD/PI, mentoring during the promotion and tenure process, and career advancement prospects for non-tenure track applicants. Letters from former mentors are not required, nor encouraged.

Letters of support should also be included from collaborators, whether or not they receive financial support from the MIRA. If support is requested, the collaborator’s letter of support should make his/her contributions to the program clear and detail the reasons he or she cannot participate in collaborative research with the PI without support from MIRA.

Where do I submit letters of support?

The letters of support must be included as an attachment to the PHS 398 Research Plan Form (Item 13 Letters of Support). See SF424 (version E) instruction guide [PDF, 7.25 MB] section G.400 pp G-146.

When should the institutional letter of support be submitted?

The institutional letter of support should be submitted as part of the Just-in-Time information and not as part of the application. This letter from the institution's authorized organizational representative must state that the institution is aware of and accepts the condition that other NIGMS research awards must be relinquished as a condition of receiving a MIRA and that if chosen to receive an award, the PI will commit a minimum of 51 percent of his or her total research effort to MIRA activities.

What is the policy on acceptance of late applications?

Applications that miss the due date and time are subject to the NIH Policy on Late Application Submission.

Can I request money for equipment in the budget?

Yes. You may request money for equipment in the first year and in any subsequent years with appropriate justification. This is not intended as a mechanism to support the purchase of "big-ticket" items that may be covered under instrument-specific funding opportunities.

Can I include a consortium contract for a collaborator?

Yes, but such requests must be extremely well-justified. NIGMS continues to encourage collaborative and interdisciplinary research when it is appropriate, and individual MIRA grantees are free to collaborate with one another or with other investigators using funds from their individual grants to support their parts of the team's research. A letter from the collaborating PI should be included, making his/her contributions to the program clear and detailing the reasons he or she cannot participate in collaborative research with the PI without support from MIRA.

Who, if anyone, in addition to the PI should be listed as "key personnel"?

Key personnel should be limited to collaborators who will be supported by a consortium, if applicable, included in the MIRA application. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. "Zero percent" effort or "as needed" is not an acceptable level of involvement for those designated as senior/key personnel. Because the focus of a MIRA application is the research program of the principal investigator, the inclusion of many other senior key personnel and their biosketches may distract reviewers from the contributions of the PI.

Whose biosketches should be included in the MIRA application?

In addition to the PI, biosketches of collaborators supported through a consortium, if applicable, are the only additional ones required. Because the focus of the MIRA application is the research program of the PI, the inclusion of other biosketches may distract reviewers from the contributions of the PI.

Does an ESI MIRA application need to be exceptionally innovative (i.e., like a DP2)?

NIGMS hopes that the ESI MIRA mechanism will enhance investigators' ability to conduct ambitious and creative research; however, there is no special emphasis on conducting exceptionally risky or out-of-the-box studies. The Institute wants to support investigators who are working to answer important and interesting questions about biological systems that have relevance to human health.

Do I need to have preliminary results?

No. Note that preliminary data are neither expected nor required, and PD/PIs may wish to indicate this prominently in the Research Strategy. In lieu of preliminary data from the PI's independent lab, feasibility of the program may be demonstrated through literature citation, data from other sources, or data generated by the applicant as a graduate student or postdoctoral fellow. Reviewers will be asked to bear this in mind, as well as the career stage of the ESI applicants.

How important is independence?

The reviewers will be asked to identify investigators with the potential to establish independent research programs that will make unique contributions to the investigator's area of science. Use the biosketch to emphasize your personal contributions to any publications resulting from work with former mentors. Evidence of independence may include preliminary data obtained since establishing an independent laboratory and publications separate from previous mentors, though these are not required and are not expected for those who apply shortly after achieving independence. The resources and environment section of the application should address laboratory space and equipment available to the investigator. A letter from a department chair or dean should attest to the commitment of the institution to the development of the PI, any specific commitments and plans for mentoring of the PI.

Who will be the scientific point of contact for my MIRA application?

The names and email addresses of the scientific contacts are listed in Section VII of the FOA. Once applications are received, they will be referred to the most relevant program official based on internal NIGMS referral procedures and guidelines. The program official assigned to your application should be visible to you in the eRA Commons by the time the application is reviewed, and the name and contact information for the program official should appear at the top of the summary statement.

Can I update my application?

The NIH policy on post-submission of grant application materials is applicable. Updates related to administrative changes and publication of articles up to 30 days before the study section meeting may be submitted to the study section SRO (scientific review officer). See Post-Submission Materials Policy FAQ.

Can I submit a video?

Per NIH notice NOT-OD-12-141, videos will be accepted by the SRO managing the review. Contact the SRO for instructions.

IV. Budget Information

What is the maximum budget I can request?

The maximum allowable budget is $250,000 direct costs per year, excluding any subcontract indirect costs, for a total project period of 5 years.

Can I submit a modular budget?

Applicants must use the R&R Detailed Budget form provided in the application package however, itemized budget information (other than equipment) is not required and will not be accepted. Instead, follow the instructions found in Section IV of PAR-20-117 regarding how to provide a total direct cost request for each budget period. This section also outlines the limited information required in the Budget Justification.

Can I request Facilities and Administrative (F&A) Costs?

Yes, F&A costs should be applied as you normally would for an NIH research grant and requested in the application as per the instructions in the SF424 R&R application guide.

Can I request money for equipment in the budget?

Yes. You may request money for equipment in any year if there is appropriate justification. Note that this is not intended as a mechanism to acquire "big-ticket" items that may be covered under instrument-specific funding opportunities. Follow the detailed instructions in the FOA under R&R Budget to include the budget request for equipment in Section C of the detailed budget form.

Should I include a separate budget form if consortium/contractual costs are requested?

No, consortium costs are expected to be rare and must be extremely well justified. In the rare instance these costs are requested, the consortium/subaward direct costs (not including consortium F&A) should be included in the "Requested Direct Costs." in Section F. of the Budget Form. In the Budget Justification, provide an estimate of the total consortium/subaward costs (direct costs plus F&A costs) for each budget period, rounded to the nearest $1,000. Also, list the individuals and organizations with whom consortium/contractual arrangements have been made and indicate whether the collaborating institution is foreign or domestic.

What information should be included in the budget justification?

Justification for budget categories detailed below should be included in the budget justification. If none of the following budget items apply to your MIRA, state “not applicable” on the budget justification page so that a system error message will be avoided when submitting the application. Additional information beyond these categories should not be provided.

Equipment: Justification for the need of equipment as well as equipment quote(s) may be included here.

Consortium/Contractual Arrangements are not anticipated in most cases and must be extremely well justified. List the individuals/organizations with whom consortium or contractual arrangements have been made and indicate whether the collaborating institution is foreign or domestic. Provide the total consortium/subaward costs for each budget period listing the total direct costs and indirect (F&A) costs separately.

F&A base: Explain any exclusions applied to the F&A base calculation.

What is the anticipated start date for MIRA?

July 1 is the earliest anticipated start date for ESI MIRA.

Should I include annual inflationary increases for salaries or other direct costs?

No. An inflationary escalation is any direct cost category should not be included, regardless of whether the annual total direct costs remain constant. If such increases are included in the submitted budget, the increases are removed from requested funds and result in decreases in the total awarded budgets of the years where they were included.

V. Review Information

How will applications to PAR-20-117 be reviewed?

The ESI MIRA applications will be reviewed by special emphasis panels organized by the Center for Scientific Review. The name and contact information for the scientific review official assigned to each application will be posted in the eRA Commons once the assignment has been made. The reviews will use the review criteria specified in the PAR-20-117 which emphasize the potential of the applicant and de-emphasize details of the experimental approach. No individual criterion scores will be assigned, only an overall impact score. Depending on the number of applications, it may be necessary to invoke a process whereby only the upper half of the applications are discussed.

What is the timeline for application, review and award?

Applications are due in October and will be reviewed in February/March for consideration by the National Advisory General Medical Sciences Council in May, with an earliest possible award date of July 1.

Will the reviewers have expertise in the subject area of my application?

Yes. The Center for Scientific Review will ensure that reviewers have the relevant expertise to review the application, bearing in mind that a MIRA is intended to support a broad program of research and the breadth of research areas that are encompassed by the NIGMS mission. Thus, reviewers will be expected to bring a broad perspective rather than detailed expertise.

How can I find the roster for the study section that will review my application?

Rosters will be available 15 days before the study section meeting.

How will the review process for MIRA differ from that for regular R01 research grant applications?

As for R01s all applicants will receive a summary statement containing the reviewers' critiques, as well as a resume and summary of the discussion for applications that were further discussed by the review panel. However, reviewers are asked to provide a single overall impact score for MIRA applications and will not provide individual criterion scores. This is intended to shift emphasis away from details of the application and the approach, and to emphasize the potential impact of the investigator's research program on the field.

How do the review criteria differ from those for a regular R01 research grant application?

The review criteria are the same, but the wording has been modified to emphasize the review of the investigator's overall NIGMS-relevant research program rather than a specific, narrowly focused project with highly tailored specific aims. Reviewers should emphasize MIRA-specific aspects of significance, investigator qualifications, innovation, approach and environment. The review criteria make it clear that preliminary data and publications since achieving independence are not required, particularly for those applying soon after achieving independence.

How will the study section arrive at a budget recommendation?

Reviewers will be asked to consider whether the budget is fully justified and reasonable in relation to the proposed work. In answering this question, it is anticipated that reviewers will consider the resources at the laboratory's disposal, and likelihood of efficient use of funds in the future. Reviewers will not be asked to recommend specific changes to the detailed budget or budget amounts.

Can I appeal the review of my MIRA application submitted to PAR-20-117?

Yes. Appeals are allowed for PARs.

If my application for MIRA is not funded, will I be able to prepare a resubmission?

No, but if you are still eligible, you may submit a new application for a receipt date in the next fiscal year.

How does the NIGMS $750,000 policy apply to MIRA?

NIGMS has a long-established policy that requires additional scrutiny of grant applications from investigators whose overall research support would exceed $750,000 in direct costs per year, inclusive of any award that might be made on the pending application. See the NAGMS Council Guidelines for Funding Decisions. In keeping with this policy, additional scrutiny will be given to MIRA applications from well-funded investigators. It is expected that a majority of applicants to the ESI MIRA program will have less than $750,000 per year in support (direct costs).

What will be Council’s involvement in the second level peer review of MIRA applications?

The summary statements for MIRA applications will be made available to the National Advisory General Medical Sciences Council in the same way as for other applications.

VI. Post Review Issues

How is scientific overlap between a MIRA and my other grants or applications evaluated?

MIRA grantees may apply for and receive research grants from other NIH institutes or centers or from other funding agencies. However, it is important to ensure the work supported by the MIRA is distinct from that supported by other sources or under review or funding consideration. A key test of scientific overlap is whether two grants would both be cited as having supported the same publication. If they would be, it is an indication that there may be scientific overlap between the two grants. NIGMS staff always evaluate the possibility of overlap with other active or pending grants prior to making an award. In addition, NIGMS staff look at the grants PIs cite on their papers at the time of each research performance progress report to check for possible scientific overlap between grants. They also evaluate the research the PI is currently conducting and compare this to the work being supported by the PI’s other research support. If it is determined that scientific overlap exists, the MIRA grant may be adjusted or terminated.

Note that early-stage investigators may apply for an ESI MIRA and an overlapping NIGMS R01 simultaneously, but only one of the applications could be funded. Established investigators cannot have an NIGMS R01 and MIRA application in at the same time.

When should I submit Just-in-Time information?

NIGMS will notify applicants when to submit Just-in-Time information. This information will be requested for all applications under consideration for funding, but the request is not meant to imply anything about the probability of an award. Be sure that the Other Support information provides a complete and accurate accounting of the annual direct costs that support research in the investigator’s laboratory, as well as any pending applications. See the MIRA webpage [PDF] for an example.

As stated in the section III, a letter from the institution's authorized organizational official is required verifying that the institution is aware of and accepts the condition that other NIGMS research awards must be relinquished as a condition of receiving a MIRA and providing a statement that if chosen to receive an award, the PI will commit a minimum of 51 percent of his or her total research effort to MIRA activities.

How will MIRA funding decisions be made?

NIGMS staff will carefully consider the study section and advisory council recommendations, including the scores and language in the summary statement and the Just-in-Time information and recent history of other grant support, in making recommendations about whether to fund a grant and at what level. As with all funding decisions, NIGMS also considers the breadth and diversity of the institute's research portfolio.

How will investigators be informed about the process?

Investigators who contact NIGMS staff will be given feedback in the usual way on their reviews and their prospects for receiving a MIRA. As always, NIGMS staff cannot make any definite statements until the plan to make an award is approved at an appropriate level. The Notice of Award is the only official notice of a government commitment to fund a MIRA.

What if I received good scores on both a DP2 application and a MIRA application and both are considered for funding?

Since both the DP2 and the ESI MIRA PAR are limited to ESI eligible investigators and both are considered to be R01 equivalent awards, you cannot receive both awards, regardless of whether or not they are both assigned to NIGMS.

What if I received good scores on an R01 assigned to a different institute of NIH and am offered both the R01 and the MIRA?

If you receive an R01 award before the MIRA has been reviewed, the MIRA application will be inactivated and will not be reviewed. If the R01 award is received after the review, but before the MIRA is awarded, the MIRA will be inactivated, and no award will be made. If both applications are considered for award at nearly the same time, then NIGMS staff will make a case by case decision about whether to fund the MIRA, or to require withdrawal of the pending R01 application before an award is made.

What if I decline the MIRA after I am notified?

Once the PI is notified by program staff that NIGMS intends to fund a MIRA and the approximate recommended funding level of the offered award, the PI should reply by email with his/her intention to accept the MIRA within one week. If the PI declines the planned award, the institution should withdraw the application immediately. If the MIRA is declined, the PI has the option to pursue other mechanisms to obtain NIGMS funding, but NIGMS will not assume any obligations as a result of this decision.

When will I find out if I will not receive a MIRA?

Applicants will not be informed that they will NOT receive an award, because an award may be made at a later date. In general, all NIH applications remain active until the automatic withdrawal date of March 31 of the fiscal year after submission. For example, grants submitted on October 3, 2020 (FY21) will be automatically withdrawn on March 31, 2022. In practice, it is expected that under this FOA, all awards will have been made by the end of the fiscal year in which the application was submitted.

VII. Award Process Information

Will carryover of an unobligated balance from one budget period of the MIRA to another be permitted?

Yes. Automatic carry over authority will apply to MIRA. Standard NIH and NIGMS policies will apply.

How much salary support can be charged against my MIRA?

Salary may be requested based on the institutional base salary level for up to an amount commensurate with the number of calendar months of effort committed to the MIRA. A lower level of salary support may be requested; NIGMS does not consider there to be an obligatory relationship between percent of annual effort and percent of annual salary recovered from the grant as long as the salary requested is not in excess of the effort committed to the grant.

I am a MIRA PI who is also a co-investigator on someone else's NIGMS grant. How will that grant be affected and how does that affect my MIRA funding?

If the MIRA application proposed to continue work on an NIGMS grant for which he or she is currently a co-investigator, the applicant's effort will be subsumed into the MIRA. When the MIRA is funded, NIGMS will inform the PI of the other grant that the MIRA PI can no longer receive funding as a co-investigator on the grant and that the PI may rebudget those funds in accordance with all relevant established policies. If after being awarded a MIRA, the MIRA PI wishes to be listed as an unpaid collaborator on another PI's NIGMS grant application, this is permitted, but the MIRA PI cannot request salary or receive funds in any form from another NIGMS award.

With acceptance of the MIRA, the special terms and conditions on the MIRA Notice of Award specify the existing NIGMS grants from which the MIRA PI can continue to receive funding. A MIRA PI, who is also a co-investigator, cannot receive funds from NIGMS grants not specified on the MIRA Notice of Award.

What kinds of grants will not be affected by the MIRA?

Non-affected grants include NIGMS grants that support research resources, training, workforce development or diversity building, clinical trials, SBIR/STTRs, conference grants, some cooperative agreements, and the portion of a multiple component grant that is strictly a core. Funds currently supporting these activities will not be included in the MIRA funding level.

How will existing administrative supplements to affected grants be handled?

These will be included in the MIRA funding level consideration and also in offsets taken to determine the MIRA award level in each year.

VIII. Post Award Concerns

How should investigators attribute support from their MIRA on publications?

It is very important for PIs to accurately attribute grant support on their publications. The terms and conditions of all NIH awards, including MIRAs, state that all research publications supported in whole or in part by NIH must include a specific acknowledgment of NIH grant support, such as: "Research reported in this publication was supported by [name of the Institute(s), Center, or other NIH offices] of the National Institutes of Health under award number [specific NIH grant number(s) in this format: R01GM987654]."

(If you have more than one grant, only cite the grant(s) that supported the research described in the article.) In addition, prior to award of any NIH competing grant application, PIs are required to provide a complete list of all their active and pending other support and, in the subsequent annual progress reports, describe any changes in other support, including new funding received: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-114.html.

Will MIRAs be eligible for administrative supplements?

MIRAs will be eligible for Research Supplements to Promote Diversity in Health-Related Research, for Research Supplement to Promote Re-Entry into Biomedical and Behavioral Research Careers, and for Administrative Supplements for Equipment Purchases. Other supplements offered by NIGMS may also be made available to MIRA grantees, depending on the intention and constraints of the particular supplement program.

Can I convert my MIRA back to an R01?

Once a MIRA has been issued, that grant cannot be converted to an R01 award. The terms and conditions of the MIRA will continue through the end of the project period unless the institution chooses to relinquish the grant early. At the end of the project period, the investigator will have the option to apply for continuation of the MIRA or to apply for a new R01 or other forms of NIGMS support.

What, if anything, will be different about the annual reporting required for MIRA?

Annual reports will be required using the Research Performance Progress Report (RPPR). The FOA includes some additional instructions consistent with the broader goals of the research program supported by MIRA and the absence of detailed specific aims. Additional information is requested that relates any new program directions to the NIGMS research mission and defines the relationship of any new other support to the activities supported by MIRA. These reporting requirements are more specific for MIRA than for an R01 research project grant. See PAR-20-117: Item 3. Reporting under Section VI. Award Administration Information for more information.

How will NIGMS manage overlap with other grants that may be awarded after MIRA?

Changes in other support must be reported in the RPPR. The relationship between other support and work supported by MIRA should be explained. NIGMS will assess whether there is sufficient scientific and budgetary overlap to warrant adjustment of the MIRA.

Can I adjust my effort on MIRA?

The requirement for at least 51 percent of total research effort must be met for the entire project period of MIRA. A PD/PI will not be permitted to reduce his/her effort level on MIRA to less than 51 percent of his/her total research effort.

Will a change of PI be allowed?

Formally, the MIRA is awarded to the institution in support of a project, not to an individual person. The institution has the right to request prior approval by NIH for the replacement of the PI. However, given the very intimate association of the ideas, expertise and record of productivity of the specific investigator with the program of research described in the research plan of the MIRA application and the scientific merit of the application as determined during peer review, it is unlikely that NIGMS would approve a permanent change of PI. A temporary change may be allowed with prior approval under circumstances such as sabbatical leave, medical condition, disability or personal or family situations such as child or eldercare needs.

What happens if the PI becomes unable to carry out the duties as PI or will be absent for more than 3 months at a time for any reason?

Standard NIH and NIGMS policies will apply.

How will NIGMS handle changes in senior/key personnel on a MIRA?

Senior/key personnel named in the Notice of Award may be replaced or eliminated from the budget with NIH prior approval. Standard NIH and NIGMS policies apply. Refer to senior/key personnel named in the NoA and see Section 8.1.2.6 Changes in status of the PD/PI in the NIH Grants Policy Statement for full details.

Will a change of grantee institution be allowed?

Standard NIH and NIGMS policies will apply; NIGMS expects the PI to maintain a similar level of effort as in the funded application.

How will the receipt of support from a MIRA affect the eligibility of supported key personnel to receive other grants?

Senior/key personnel other than the PI may receive support from other awards, including other MIRA grants on which they are also not the PI. The PI of a MIRA will not be awarded other support from NIGMS, nor may a MIRA PI receive funds from the grants of another NIGMS investigator.

Will no-cost extensions be permitted?

Standard NIH and NIGMS policies will apply.

What will happen at the end of the 5-year MIRA grant project period?

MIRAs are renewable through a competing application and peer review process.

If I submit a renewal application for my MIRA, is it possible to receive an increased budget?

Yes, MIRAs with modest budgets that have been very productive and score very well could receive budget increases. MIRA budgets will be set based on a number of factors. Scoring well on renewal will not by itself guarantee a budget increase.

IX. Prior Approval Issues

What changes will require NIH written prior approval?

Standard NIH and NIGMS policies will apply.

Prior approval is needed for the following:

  • A change in scope, including, but not limited to, a change from the approved use of vertebrate animals or involvement of human subjects, select agents or human embryonic stem cells
  • Additional no cost-extensions beyond a first no-cost extension or late notification of an initial no-cost extension
  • Change in status of the PI or senior/key personnel named in the Notice of Award
  • Change in grantee organization or organization status
  • Addition of a foreign component if not included in the original application, including a significant new foreign collaboration, requires NIGMS' prior approval; , MIRA funds may be used to support a subcontract at a foreign institution only if the collaboration is essential to the PI's research program, represents a unique scientific opportunity and cannot be supported by the collaborator.

What approvals are required to add animal studies to my MIRA project, or when studies included as delayed onset in the application are to be initiated?

You will need to notify your NIGMS program officer and grants management specialist of any significant changes to your animal research. Addition of animal studies and/or initiation of "delayed onset" studies requires NIGMS and NIH Office of Laboratory Welfare (NIH OLAW) administrative review prior to the start of these animal studies if you will be using funds from your MIRA. Approval from your IACUC for any new animal studies that will be carried out or for any significant changes to your approved animal studies is also necessary. You will need to provide an updated VAS section and NIH OLAW will need to provide their written approval that you may proceed with your animal studies using your NIGMS MIRA funds including for the purchase of any animals. For details, please see NIH Notice NOT-OD-14-126.

If you conduct research involving animals on your MIRA without your IACUC approval, NIH may reduce the amount of your award or request return of funds, and you may not use any animal data obtained during this time for any activity related to the grant award.

MIRA awardees can submit a prior approval request in writing to their program officer to add human subjects research to their MIRA or to initiate "delayed onset" studies. Prior approval requests should contain a complete Protection of Human Subjects section as described in the current MIRA funding opportunity announcement.

What approvals are required to add human subject studies to my MIRA project or to initiate “delayed onset” human subject studies?

MIRA awardees can submit a prior approval request in writing to their program director to add human subjects research to their MIRA or to initiate “delayed onset” studies. Prior approval requests should contain a complete Protection of Human Subjects section as described in the current MIRA funding opportunity announcement.

Who will be the program officer for my MIRA?

Your program officer's name will be on your summary statement and in the NIH Commons.